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QOCA PORTABLE ECG MONITORING DEVICE
User Manual

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Summary of Contents for Quanta Computer QOCA

  • Page 1 QOCA PORTABLE ECG MONITORING DEVICE User Manual...
  • Page 2: Table Of Contents

    TABLE OF CONTENTS Safety Notes ............... 5 Product Overview ............11 Indication for Use ............11 Package Contents ............. 12 Product Configurations ........14 Components .............. 15 Sensor ..............15 Charger ..............17 Body Patch ............18 Sensor Holder & Cable ........19 12-unit Charger (Charging 12 sensors at the same time) ............
  • Page 3 Enabling Bluetooth ........... 24 Getting Started ..............25 Creating a Profile ............25 Pairing ................ 27 Wearing the ECG Sensor ......... 28 Wearing the sensor holder........29 Removing the ECG Sensor from the Holder ..32 Wearing the body patch ........... 33 The Q-ecg App ..............
  • Page 4 Measuring ECG when Bluetooth is Disconnected 46 Additional Information ............ 48 LED Indicators ............48 Sensor Status Indicator ........48 Cleaning ..............50 ECG Electrode Information ........51 Specifications ............52 Sensor Specifications ........52 Charger Specifications ........54 Troubleshooting ............54 Gateway mode information ........
  • Page 5 Regulatory Marks ..........60 Supplier’s Declaration ..........63 CIB418-01...
  • Page 6: Safety Notes

    Damaged or faulty accessories and electrodes should not be used.  When the QOCA PORTABLE ECG MONITORING DEVICE is low on battery power, it will automatically stop taking measurements and the corresponding indicator lights will blink. Please charge the sensor’s battery as soon as it shows a low battery state.
  • Page 7 (e.g., using a blood pressure monitor will affect the ECG’s pulse measurement).  Avoid using other electronic devices when the QOCA PORTABLE ECG MONITORING DEVICE is taking measurements. If using another other electronic device is necessary, please check to ensure the ECG is continuing to take measurements normally.
  • Page 8  Pay attention to ensure that the QOCA PORTABLE ECG MONITORING DEVICE is not swallowed by pets or children.  Cardiac pacemakers or other electrical stimulators may affect the accuracy of the measurements of the QOCA PORTABLE ECG MONITORING DEVICE.
  • Page 9 Do not expose QOCA PORTABLE ECG MONITORING DEVICE to extreme temperatures, extremely moist environments, dust, or direct sunlight.  Do not clean the QOCA PORTABLE ECG MONITORING DEVICE with corrosive or abrasive cleaning agents.  The QOCA PORTABLE ECG MONITORING DEVICE and its accessories should be disposed of properly.
  • Page 10 DEVICE ’s use is not intended for use with infants weighing less than 45lbs. (20 kg).  The expected service life of the QOCA PORTABLE ECG MONITORING DEVICE is 2 years.  If you feel very itching or find redness when wearing the body patch, remove the body patch immediately.
  • Page 11 (such as electrosurgical equipment and some respiratory sensors); if such devices are used at the same time, it may cause adverse consequences. For procedures that require the use of high-frequency surgical equipment, QOCA PORTABLE ECG MONITORING DEVICE should be removed beforehand. ...
  • Page 12: Product Overview

    PRODUCT OVERVIEW Indication for Use The QOCA PORTABLE ECG MONITORING DEVICE is intended for non-invasive measurement of a functional Electrocardiogram (ECG) and heart rate (HR) in hospitals, healthcare institutes, and home environments by trained medical professionals and trained adult. The QOCA...
  • Page 13: Package Contents

    Package Contents After purchasing the QOCA PORTABLE ECG MONITORING DEVICE , please check the product package to ensure that the following items are included: Q-ecg-wu3 product package Protection bag x 1 Charger x 1 ECG Sensor x 1 USB Charging...
  • Page 14 Q-ecg-wu5 product package Protection bag x 1 Charger x 1 ECG Sensor x 1 USB Charging User Manual x 1 Cable x 1 CIB418-01...
  • Page 15: Product Configurations

    Product Configurations The following table lists the sensor related items included in the various packages available for the QOCA Portable ECG Monitoring Device. CIB418-01...
  • Page 16: Components

    Components Sensor Front Power Button Battery LED (see LED Indicators for more information) Indicator LED (see LED Indicators for more information) CIB418-01...
  • Page 17 Back Charging Contacts Holder Connectors Label Area NOTE: Electrode button connector will support plug in/off test under 1000 times. CIB418-01...
  • Page 18: Charger

    Charger Charging Contacts USB Charging Port CIB418-01...
  • Page 19: Body Patch

    Body Patch Front Exterior (with pocket closed) Contact Point Material Made from Nonwoven CIB418-01...
  • Page 20: Sensor Holder & Cable

    Sensor Holder & Cable Front Sensor Connectors Material Made from Polydefin Foam Cable Connector CIB418-01...
  • Page 21 Back Electrode Connectors IMPORTANT: If any damage to the wire shielding is found on the holder, replace immediately. CIB418-01...
  • Page 22: 12-Unit Charger (Charging 12 Sensors At The Same Time)

    12-unit Charger (Charging 12 sensors at the same time) Specification : Charging indicator LED on Sensor 5 ~ 35⁰C (Sensor working temp is 5 ~ Working temp 35⁰C when it is charging) Storage temp -20 ~ 60⁰C Input 12V/2A Size 241.3 mm * 166.4 mm * 66.25 mm NOTE: 12-unit charger can only be used by trained ...
  • Page 23: Product Requirements

    Product Requirements In order to properly use the QOCA PORTABLE ECG MONITORING DEVICE the following items are required: For Body Patch:  The ECG Sensor  The Body Patch  A Bluetooth-enabled Android Smartphone* (with Android version 5.x or above and a display resolution of 1920x1080 or 2560x1440) or iPhone (iOS 12 above) ...
  • Page 24: Before You Start

    BEFORE YOU START Before you start using the QOCA PORTABLE ECG MONITORING DEVICE you must: Charge the battery on the Sensor Install the Q-ecg app on your Android smartphone Enable Bluetooth on your smartphone Charging the Battery Sensor Adapter Charger...
  • Page 25: Installing The App

    To charge the battery: Plug the charger’s AC adapter (with 5V/1A and conform to standard 60950) into a power source (i.e., wall outlet) and connect the charging cable. Connect the other end of the charging cable to the charger. AC adaptor part is not included in the package. Please must use compatible AC adaptor.
  • Page 26: Getting Started

    GETTING STARTED Once you have completed the steps described in Before You Start, you can begin using the QOCA PORTABLE ECG MONITORING DEVICE by following these steps: Create a profile in the Q-ecg app Pair your smartphone to the ECG sensor via...
  • Page 27  Name  Gender  Birthday  Height  Weight  [Optional] Resting Heart Rate NOTE: When filling in your resting heart rate, you may ask a trained medical professional to measure your resting heart rate, or determine your resting heart rate by measuring your heart rate after at least 5 minutes of inactivity.
  • Page 28: Pairing

    Pairing After creating a profile, please enter the pairing page. To pair the sensor to your smartphone: When enter the pairing page, it would show the nearby BLE devices. Please select the name “CIBXSXXXXXXX” which is the same as serial number on the back of sensor.
  • Page 29: Wearing The Ecg Sensor

    Wearing the ECG Sensor Depending on the model you have purchased, you may either wear the ECG sensor using the provided body patch, or wear the ECG sensor the sensor holder. IMPORTANT: When wearing the ECG sensor directly you must use compatible electrodes (sold separately) for the device to work properly.
  • Page 30: Wearing The Sensor Holder

    Wearing the sensor holder To wear the ECG sensor directly on your body, follow the directions below: Attach an ECG electrode to each of the 3 connectors on the back of the sensor holder (see image below). NOTE: For more information on electrode specifications, see ECG Electrode Information.
  • Page 31 Attach the ECG sensor to the front of the sensor holder so that all four holder connectors on the sensor are properly clicked into the four sensor connectors on the holder (see image below). NOTE: Once connected, the status indicator on the sensor will light green then slowly flash indicating that the sensor is connected to the holder but that the holder has not properly made contact with a body.
  • Page 32 Adhere the electrode attached to the cable to the area under your right collarbone (see image below). Once the ECG sensor is properly positioned on your body, wait half a minute then check the Q-ecg app to see if a real-time ECG reading is shown on the main screen on the app.
  • Page 33: Removing The Ecg Sensor From The Holder

    WARNING: When wearing the ECG sensor directly on your body, ensure that all 3 electrodes are firmly adhered to your body. Ensure that no parts of the sensor holder are dangling (as shown below), which can lead to damage or cause the device to short-circuit if the electrodes comes into contact with the electrical contacts on another powered device.
  • Page 34: Wearing The Body Patch

    Wearing the body patch The following steps describe the body patch wearing process: Step1. Attach the Device on the body patch before put on body. Step2. Wipe with alcohol cotton on the left chest. Step3. Left hand naturally put down. Step4.
  • Page 35 Step5. Hand pressure on the body patch (especially on the connect point) for 30 seconds. IMPORTANT: The Patch needs 24 hours to fully stick to your skin, we recommend showering briefly with your back to the water, and avoid any activities that cause sweating during this period.
  • Page 36: The Q-Ecg App

    THE Q-ECG APP Main Screen Once you have successfully paired and worn the ECG sensor, the Q-ecg app’s main screen will display on your mobile device. The main screen (shown below) displays a real-time ECG which should be shown to a medical professional for evaluation.
  • Page 37 Item Description Menu Tap to access the app menu. For more Button information see Menu. Displays the profile settings that were entered during the profile creation process. For more information on changing profile settings, see Quick Search Scroll Bar The quick search scroll bar allows you to quickly scroll to a different point in the ECG history by swiping left or right on the scroll bar.
  • Page 38 scroll bar that are dark blue feature ECG readings. Tap Hide to return to the main toolbar for the History screen. Profile. Real- Displays your real-time ECG in 5 Time second intervals. Battery Displays the current charge level of the Status battery.
  • Page 39: Menu

    NOTE: When using the Q-ecg app, the default “Back” button on your Android smartphone will become disabled. To exit the Q-ecg app, you must use the “Quit” button in the Q-ecg app’s menu. For more information, see Setting It is able to set ECG sensor in different mode. But this feature is not open for user, only for special group.
  • Page 40: History

    History Tap History in the Q-ecg app menu to view a scrollable and scalable ECG history. The following items can be found on the ECG history screen: CIB418-01...
  • Page 41 Item Description Tap to view an ECG from a Date Button different date. Menu Button Tap to access the app menu. CIB418-01...
  • Page 42 Tap to display your ECG history. Swipe left or right to ECG History move to forward or backward in your ECG history. Tap to adjust/rescale the view Display of the ECG history. For more Options Button information, see Display Options. Tap to open the quick search Quick Search scroll bar, see Quick Search...
  • Page 43 Date When you tap the date button in the History screen, a calendar view will appear. Dates on which you recorded an ECG are circled. Tap on a circled date to view your ECG on days when an ECG data from that day. NOTE: The Q-ecg app stores ECG data for up to 14 days (Q-ecg-wu3) up to 5 days (Q-ecg-wu5)
  • Page 44 activity (in millivolts). Adjust the display options for the ECG history for a more detailed or a more general view of the ECG data. The following display options are available when viewing the ECG history:  Speed: Using a lower speed option will shrink the ECG along the horizontal axis of the grid, and using a higher speed option will expand the ECG along the horizontal axis of the grid.
  • Page 45 Quick Search Scroll Bar The quick search scroll bar allows you to quickly scroll to a different point in the ECG history by swiping left or right on the scroll bar. The numbers on the scroll bar represent the hour of the day shown, and each point on the scroll bar represents 10 minutes.
  • Page 46: Profile

    Profile Tap Profile in the Q-ecg app menu to change the profile settings used in the Q-ecg app. Follow the same instructions in Creating a Profile to change the profile settings. Pairing Tap Pairing in the Q-ecg app menu to pair/re-pair the ECG sensor to an Android smartphone.
  • Page 47: Setting

    Setting It is able to set ECG sensor in different mode. But this feature is not open for user, only for special group. Please contact us, if you need this function. Quit Tap Quit in the Q-ecg app to exit the app. Measuring ECG when Bluetooth is Disconnected The device is designed with embedded storage so that after initial setup is complete if the Bluetooth connection...
  • Page 48 CIB418-01...
  • Page 49: Additional Information

    ADDITIONAL INFORMATION LED Indicators The following tables describe the indicators on both the sensor and charger: Sensor Status Indicator Event Action Behavior • Both Battery LED Press power & Indicator LED Power on button flashing green 3 times • Solid blue light for both Battery LED Long press and Indicator LED...
  • Page 50 • Indicator LED User do not Lead off flashing orange wear device light When it’s lead Event on and press • Indicator LED Recording power button flashing blue light • Battery LED Low battery N/A flashing orange light • Battery LED Charging Put on charger flashing blue light...
  • Page 51: Cleaning

    Cleaning The table below describes the appropriate cleaning methods for each item included with the QOCA PORTABLE ECG MONITORING DEVICE: Item Cleaning Method Sensor Wipe with a dry cloth when it’s dirty. And clean it every day if it is frequently used.
  • Page 52: Ecg Electrode Information

    ECG Electrode Information When using the Sensor Holder for the QOCA PORTABLE ECG MONITORING DEVICE, you must use compatible electrodes (sold separately) for the ECG sensor to work properly. Suggested electrodes include Kendall Ag/AgCl electrodes, or any electrodes that meeting the following specifications: ...
  • Page 53: Specifications

    Specifications Sensor Specifications Continuous ECG data acquisition and calculation Measuring Lead: Lead 2 Frequency Response: Monitor 0.05 to 40 Hz (-3db) Heart rate measurement range*: 30 – 240 bpm** Heart rate accuracy: ± 3 bpm or ±3% whichever is greater ECG Sensor Differential Input Impedance: >...
  • Page 54 Energy Calculated from HR and activity Expenditure data Detect when the sensor gets Lead-off loosened from holder or body Detection patch Bluetooth BLE 5.0: Transmit Data distance: 10 meters (open Transmission space) Micro USB cable USB2.0 Battery 3.8V/530mAh or 3.8V/220mAh Storage mode : 14Days or 6Days Battery Life @ 256Hz Sample rate...
  • Page 55: Charger Specifications

    Weight 20 ± 0.5 g 42 mm (L) x 40.0 mm (W) x 12.0 Dimension mm (H) ±0.2 mm Troubleshooting Cannot pair the QOCA PORTABLE ECG MONITORING DEVICE with the Q-ecg app. Refer to the notes listed in Pairing. CIB418-01...
  • Page 56: Gateway Mode Information

    Gateway mode information When using QOCA PORTABLE ECG MONITORING DEVICE, the data needs to be transmitted from many different ECG-sensors to server at the same time. The Gateway part is not included in the package. You must use compatible gateway device for the multi-ECG-sensors to work properly.
  • Page 57 The gateway mode is designed to collect multi-ECG- sensors data information only. CIB418-01...
  • Page 58: Customer Support

    Customer Support For additional technical information, contact Quanta Customer Support Department. Quanta Computer Inc.(QCI) Address: No. 188, Wenhua 2nd Rd., Guishan Dist., Taoyuan City 333, Taiwan TEL: +886-3-327-2345 FAX: +886-3-318-4207 Email: MedicalSales@quantatw.com EU Representative EU Representative: MedNet GmbH Address: Borkstrasse 10, 48163 Münster, Germany...
  • Page 59: Federal Communications Commission (Fcc) Statement

    Federal Communications Commission (FCC) Statement The FCC ID is HFSCIB 15.21 You are cautioned that changes or modifications not expressly approved by the part responsible for compliance could void the user’s authority to operate the equipment. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: This device may not cause interference and This device must accept any interference, including...
  • Page 60 guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: ...
  • Page 61 Regulatory Marks The QOCA PORTABLE ECG MONITORING DEVICE conforms to the following regulatory requirements. Administrative Regulations on Low Power Radio Waves Radiated Devices (930322) Article 12 Without permission granted by the NCC, any company, enterprise, or user is not allowed to change frequency,...
  • Page 62 devices must be susceptible with the interference from legal communications or ISM radio wave radiated devices. CE Mark: Indicates that the body sensor has been certified and conforms to EC Directive 93/42/EEC on medical devices. Type applied part Indicates that the body sensor is classified as electrical or electronic equipment requiring proper disposal (WEEE...
  • Page 63 Indicates the manufacturer's name and address To indicate on the rating plate that the equipment is suitable for alternating current only; to identify relevant terminals. Indicates the need for the user to consult the instructions for use for important cautionary information such as warnings and precautions that cannot, for a variety of reasons, be...
  • Page 64 Supplier’s Declaration The QOCA PORTABLE ECG MONITORING DEVICEconforms to the international EN 60601-1 and EN 60601-1-2 standards for electromagnetic compatibility with medical electrical devices and systems. Manufacturer’s declaration-electromagnetic emissions The Q-ecg-wu3/Q-ecg-wu5 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below.
  • Page 65 Group 1 The Q-ecg-wu3/Q-ecg- emissions wu5 uses RF energy only CISPR 11 for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. Class B The Q-ecg-wu3/Q-ecg- emissions wu5 is suitable for use in CISPR 11 all establishments,...
  • Page 66 Manufacturer’s declaration-electromagnetic immunity The Q-ecg-wu3/Q-ecg-wu5 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the Q-ecg-wu3/Q-ecg-wu5 should assure that it is used in such an environment. Immun IEC 60601 Complianc Electromagnetic ity test...
  • Page 67 should be at least kV,±15 kV,±15 61000- Electric + 2kV for + 2kV for Mains power al fast power power quality should be transie supply supply lines that of a typical nt/burst lines home healthcare environment. + 1kV for applicable 61000- input/outp ut lines...
  • Page 68 Voltag Voltage Voltage Mains power e Dips, dips: dips: quality should be short that of a typical interru home healthcare 0 % UT; 0 % UT; ptions environment. If the user of the Q- cycle cycle voltage ecg-wu3/Q-ecg- 0 % UT; 0 % UT;...
  • Page 69 magnet 50 Hz of a typical location ic field or 60 in a typical home healthcare environment. 61000- NOTE UT is the a.c. mains voltage prior to application of the test level. Manufacturer’s declaration-electromagnetic immunity The Q-ecg-wu3/Q-ecg-wu5 is intended for use in the electromagnetic environment (for home and professional healthcare) specified below.
  • Page 70 healthcare environment) Conducted 3 Vrms: 3 Vrms: Portable and mobile RF communications 0,15 0,15 MHz MHz – – 80 MHz 61000-4-6 80 MHz equipment should be used 6 Vrms: no closer to any 6 Vrms: part of the Q- in ISM ecg-wu3/Q-ecg- in ISM wu5 including...
  • Page 71 80 % AM 61000-4-3 at 1 Recommended 10 V/m separation distance: 80 MHz – 2,7 GHz 10 V/m d = 1,2 √P 80 % AM 80 MHz at 1 kHz d = 1,2 √P – 2,7 80MHz to 800 80 % AM d = 2,3 √P at 1 800MHz to 2,7...
  • Page 72 distance in metres (m). Interference may occur in the vicinity of equipment marked with the following symbol: NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
  • Page 73 Recommended separation distance between portable and mobile RF communications equipment and the Q-ecg-wu3/Q-ecg-wu5 The Q-ecg-wu3/Q-ecg-wu5 is intended for use in an electromagnetic environment (for home and professional healthcare) in which radiated RF disturbances are controlled. The customer or the user of the Q-ecg-wu3/Q-ecg-wu5 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Q-ecg-...
  • Page 74 150 kHz to 80 MHz to 800 MHz to power of 80 MHz 800 MHz 2,7 GHz transmitter d =1,2√P d =1,2√P d =2,3√P 0,01 0,12 0,12 0,23 0,38 0,38 0,73 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output...
  • Page 75 NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. CIB418-01...

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